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Aranesp 25mcg/ml Inj, 1ml

Manufacturer AMGEN Active Ingredient Darbepoetin Alfa Vials(dar be POE e tin AL fa) Pronunciation dar-be-POE-e-tin AL-fa
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor. @ COMMON USES: It is used to treat anemia.
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Drug Class
Erythropoiesis-Stimulating Agent (ESA)
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Pharmacologic Class
Recombinant Human Erythropoietin Analog
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Pregnancy Category
Category C
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FDA Approved
Nov 2001
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Aranesp is a medicine that helps your body make more red blood cells. It's used to treat anemia (low red blood cell count) in people with chronic kidney disease or in some cancer patients receiving chemotherapy. It works like a natural substance in your body called erythropoietin.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein during dialysis. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.

Continue using this medication as directed by your doctor or healthcare provider, even if you are feeling well. It is essential to handle the medication correctly:

Do not shake the medication.
 Do not use the medication if it has been shaken.
Do not use the medication if it has been frozen.
 Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it is cloudy, leaking, or contains particles.
 Do not use the medication if the solution has changed color.
* Avoid injecting into red or irritated skin.

After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have any questions or concerns, consult your doctor or pharmacist.

Storage and Disposal

Store this medication in the refrigerator at all times. Do not freeze. If you are unsure about storage or disposal, consult your doctor or pharmacist.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Adhere strictly to the prescribed dosing schedule and route of administration.
  • Maintain adequate iron intake, as iron is essential for Aranesp to work effectively. Your doctor may prescribe iron supplements.
  • Monitor your blood pressure regularly at home as instructed by your doctor, and report any significant changes.
  • Report any new or worsening symptoms immediately to your healthcare provider, especially signs of blood clots (e.g., chest pain, shortness of breath, leg pain/swelling) or allergic reactions.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication and route. For CKD anemia (non-dialysis or dialysis): 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. For chemotherapy-induced anemia: 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks.
Dose Range: 0.45 - 500 mg

Condition-Specific Dosing:

Chronic Kidney Disease (CKD) Anemia (non-dialysis and dialysis): Initial: 0.45 mcg/kg IV or SC once weekly, or 0.75 mcg/kg SC once every 2 weeks. Adjust dose to maintain hemoglobin levels between 10-11 g/dL. Do not exceed 11 g/dL.
Chemotherapy-Induced Anemia: Initial: 2.25 mcg/kg SC once weekly, or 500 mcg SC once every 3 weeks. Adjust dose to maintain hemoglobin levels sufficient to avoid red blood cell transfusions. Discontinue if chemotherapy is completed or if 8 weeks of therapy have passed without response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: For CKD anemia (ages 1 month to 16 years): Initial: 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain hemoglobin levels between 10-12 g/dL. Do not exceed 12 g/dL.
Adolescent: For CKD anemia (ages 1 month to 16 years): Initial: 0.45 mcg/kg IV or SC once weekly. Adjust dose to maintain hemoglobin levels between 10-12 g/dL. Do not exceed 12 g/dL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment based on renal function alone; dosing is guided by hemoglobin response in CKD patients.
Moderate: No specific dose adjustment based on renal function alone; dosing is guided by hemoglobin response in CKD patients.
Severe: No specific dose adjustment based on renal function alone; dosing is guided by hemoglobin response in CKD patients.
Dialysis: Dosing for CKD patients on dialysis is the same as for non-dialysis CKD patients, guided by hemoglobin response. IV route is often preferred for patients on hemodialysis.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended. Use with caution due to limited data.

Pharmacology

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Mechanism of Action

Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It interacts with the erythropoietin receptor on progenitor cells in the bone marrow to stimulate red blood cell production and differentiation. Darbepoetin alfa has a longer half-life than epoetin alfa due to its increased glycosylation, allowing for less frequent dosing.
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Pharmacokinetics

Absorption:

Bioavailability: Subcutaneous: Approximately 37% (range 28-49%)
Tmax: Subcutaneous: Approximately 48 hours (range 12-108 hours)
FoodEffect: Not applicable (administered parenterally)

Distribution:

Vd: Approximately 0.06 L/kg
ProteinBinding: Not extensively protein bound
CnssPenetration: Limited

Elimination:

HalfLife: Intravenous: Approximately 21 hours; Subcutaneous: Approximately 49 hours
Clearance: Approximately 0.02 L/hr/kg (IV)
ExcretionRoute: Primarily catabolic degradation; minimal renal excretion of intact drug.
Unchanged: Less than 10% (renal excretion)
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Pharmacodynamics

OnsetOfAction: Increase in reticulocytes typically seen within 7-10 days; significant increase in hemoglobin usually within 2-6 weeks.
PeakEffect: Peak hemoglobin response typically observed after several weeks of therapy.
DurationOfAction: Due to its long half-life, effects persist for several weeks after the last dose, allowing for less frequent administration (weekly or bi-weekly).

Safety & Warnings

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BLACK BOX WARNING

Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. ESAs are not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. In patients with CKD, ESAs increase the risk of death, serious cardiovascular events, and stroke. In patients with cancer, ESAs increase the risk of tumor progression or recurrence and decrease survival.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Fast heartbeat
 Shortness of breath
Sudden weight gain or swelling in the arms or legs
 Weakness on one side of the body
Trouble speaking or thinking
 Changes in balance
Drooping on one side of the face
 Blurred eyesight
Feeling confused
 Cool or pale arm or leg
Difficulty walking
 Dizziness or passing out
Excessive sweating
 Seizures
Feeling extremely tired or weak
 Pale skin

Blood Clots: Seek Medical Help Right Away

If you experience any of the following symptoms, which may indicate a blood clot, contact your doctor immediately:

Chest pain or pressure
 Coughing up blood
Shortness of breath
 Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing

Severe Skin Reaction: Seek Medical Help Right Away

In rare cases, this medication can cause a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can lead to serious health problems and even death. If you notice any of the following symptoms, seek medical help immediately:

 Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
 Sores in your mouth, throat, nose, or eyes

Other Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor if you notice any of the following:

Stomach pain
 Cough

If you experience any other side effects that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden severe headache, confusion, vision changes (signs of high blood pressure)
  • Chest pain, shortness of breath, pain in arm/shoulder/jaw (signs of heart attack)
  • Sudden numbness or weakness on one side of the body, sudden trouble speaking or seeing (signs of stroke)
  • Pain, swelling, warmth, or redness in an arm or leg (signs of deep vein thrombosis)
  • Unusual tiredness, dizziness, or pale skin (signs of worsening anemia or pure red cell aplasia)
  • Rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing (signs of allergic reaction)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

If you have a known allergy to darbepoetin alfa or any component of this drug. Describe the allergic reaction and symptoms you experienced.
 If you have high blood pressure.
If you have been diagnosed with Pure Red Cell Aplasia (PRCA), a specific type of anemia.
 If you have cancer, discuss this with your doctor to determine the best course of action.

Additionally, this medication may interact with other drugs or health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
 Any natural products or vitamins you are using
* Existing health problems or concerns

Your doctor will assess the safety of taking this medication with your other drugs and health conditions. Do not initiate, stop, or adjust the dose of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are scheduled to undergo surgery, consult with your doctor, as you may need to take an additional medication to prevent blood clots while using this drug.

Regular blood pressure monitoring is crucial, as this medication can cause high blood pressure. Adhere to your doctor's instructions for checking your blood pressure. Additionally, follow your doctor's guidance for having blood work checked, and discuss any concerns or questions with your doctor.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.

This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Polycythemia (excessively high red blood cell count), which can lead to hyperviscosity syndrome and increased risk of thrombotic events (e.g., stroke, heart attack, blood clots).

What to Do:

There is no specific antidote. Management involves phlebotomy (blood removal) to reduce hemoglobin and hematocrit levels, and supportive care to manage symptoms and complications. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.

Drug Interactions

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Moderate Interactions

  • Iron supplements (may be needed to support erythropoiesis, but not a direct interaction)
  • Other erythropoiesis-stimulating agents (concurrent use is not recommended)

Monitoring

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Baseline Monitoring

Hemoglobin (Hb)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Iron status (serum ferritin, transferrin saturation [TSAT])

Rationale: To ensure adequate iron stores for optimal erythropoiesis. Iron supplementation may be required.

Timing: Prior to initiation of therapy.

Blood Pressure (BP)

Rationale: To establish baseline and identify pre-existing hypertension.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: To assess overall hematologic status and rule out other causes of anemia.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Hemoglobin (Hb)

Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.

Target: CKD: 10-11 g/dL (do not exceed 11 g/dL). Chemotherapy-induced anemia: Lowest Hb level sufficient to avoid transfusions.

Action Threshold: If Hb increases by >1 g/dL in any 2-week period, or exceeds target range, reduce dose. If Hb falls below target or does not increase, consider dose increase or investigate other causes of anemia.

Blood Pressure (BP)

Frequency: Regularly, especially during the initial phase of therapy.

Target: Individualized, within patient's normal range.

Action Threshold: If significant increase in BP or new onset hypertension, manage appropriately with antihypertensive therapy.

Iron status (serum ferritin, TSAT)

Frequency: Monthly or as clinically indicated.

Target: Ferritin >100 ng/mL, TSAT >20%.

Action Threshold: If iron deficiency, initiate or increase iron supplementation.

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Symptom Monitoring

  • Symptoms of hypertension (headache, dizziness, blurred vision)
  • Symptoms of thrombotic events (chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness)
  • Symptoms of allergic reactions (rash, itching, hives, swelling, difficulty breathing)
  • Symptoms of pure red cell aplasia (sudden worsening of anemia, fatigue, pallor)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown adverse effects at doses higher than clinical doses.

Trimester-Specific Risks:

First Trimester: Potential for adverse developmental effects observed in animal studies at high doses.
Second Trimester: Potential for adverse developmental effects observed in animal studies at high doses.
Third Trimester: Potential for adverse developmental effects observed in animal studies at high doses.
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Lactation

It is not known whether darbepoetin alfa is excreted in human milk. The decision to discontinue breastfeeding or discontinue the drug should take into account the importance of the drug to the mother and the potential risks to the infant. Caution should be exercised.

Infant Risk: Not available (lack of data on presence in human milk or effects on breastfed infant).
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Pediatric Use

Darbepoetin alfa is approved for the treatment of anemia due to CKD in pediatric patients 1 month of age and older. Safety and efficacy in pediatric patients with chemotherapy-induced anemia have not been established. Dosing is weight-based and adjusted to target hemoglobin levels.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more sensitive to the effects of ESAs, particularly regarding cardiovascular events. Dose selection should be cautious, generally starting at the low end of the dosing range.

Clinical Information

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Clinical Pearls

  • Always assess iron status (ferritin and TSAT) before and during darbepoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
  • Do not administer darbepoetin alfa more frequently than once weekly for CKD or once weekly/every 3 weeks for chemotherapy-induced anemia. More frequent administration does not improve response and may increase risks.
  • Closely monitor hemoglobin levels and adjust dose to avoid exceeding target ranges (especially 11 g/dL for CKD patients), as higher hemoglobin levels are associated with increased cardiovascular and thrombotic risks.
  • Educate patients thoroughly on the black box warnings, particularly the risks of blood clots and hypertension, and instruct them to report any concerning symptoms immediately.
  • For patients on hemodialysis, the IV route is generally preferred for convenience and potentially better bioavailability, but SC route is also effective.
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Alternative Therapies

  • Epoetin alfa (Epogen, Procrit, Retacrit) - another ESA with a shorter half-life, requiring more frequent dosing.
  • Methoxy polyethylene glycol-epoetin beta (Mircera) - another long-acting ESA.
  • Blood transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective).
  • Iron supplementation (oral or intravenous) - often used adjunctively with ESAs or as primary treatment for iron deficiency anemia.
  • Correction of underlying causes of anemia (e.g., nutritional deficiencies, chronic blood loss, inflammation).
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Cost & Coverage

Average Cost: Varies significantly by dose and formulation (e.g., prefilled syringe vs. vial). Can range from hundreds to thousands of dollars per dose. per dose
Insurance Coverage: Typically covered under medical benefit or as a specialty drug under pharmacy benefit. Often requires prior authorization and is subject to high co-pays or co-insurance.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or healthcare provider for guidance. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.